This application responds to broad challenge grant area (04): Clinical Research and specific Challenge Topic, 04-MD-101: Enhancing Recruitment and Retention of Ethnic Minorities in Clinical Trials. Sickle cell disease (SCD) is a genetic disorder affecting primarily African-Americans in the United States. Since the 1970s, efforts have been made to develop efficacious treatments for SCD;however, low overall enrollment and poor retention has slowed progress towards identification of efficacious medical and psychosocial treatments. We aim, in Phase 1, to delineate factors associated with engagement in clinical trials for pediatric patients with SCD and their caregivers using questionnaires (n = 50) and follow-up interviews (n = 10-15) from 4 groups: (1) pediatric patients with SCD (ages 6-18 years) and their caregivers treated at the Marian Anderson Sickle Cell Center of St. Christopher's Hospital for Children;(2) pediatric patients with SCD (ages 6-18 years) and their caregivers treated in the community;(3) pediatric patients with asthma (ages 6-18 years) and their caregivers treated at St. Christopher's Hospital for Children;and (4) young adults with SCD (ages 18-39 years) and their caregivers. Based on Phase 1 findings, we will develop a structured recruitment and retention protocol implemented through patient navigation. The protocol will include screening for perceived barriers and benefits to participation and provide targeted strategies to decrease barriers and increase acceptability. In Phase 2, we will test the feasibility and effectiveness of the protocol with patient navigation (a health care professional from the SCD community) to increase recruitment and retention rates and socioeconomic diversity of participants with SCD and their caregivers in a current NHLBI-funded psychosocial clinical trial. Through collaboration among The Children's Hospital of Philadelphia (CHOP), the Marian Anderson Sickle Cell Center, and community organizations, we will develop community-generated, empirically-based strategies to support engagement in clinical trials for pediatric patients with SCD and their caregivers and increase the likelihood that current and future clinical trials will meet their aims in identifying efficacious treatments. CHOP contributes substantially to the local economy. In 2008, CHOP's operations created and supported over 16,882 jobs in the region, total economic impact was over $2.01 billion, and CHOP received more total research support than any other children's hospital in the United States. St. Christopher's Hospital for Children is a major pediatric center including a 150-bed in-patient facility, a teaching and education center and research laboratories (through its affiliation with Drexel University College of Medicine), which serves as a regional referral hospital for children from around Philadelphia and the Delaware Valley. This proposal will create 3 positions for ethnic minority health care professionals (Research Coordinator;Research Assistant, Patient Navigator), bolster 3 community agencies that advocate for ethnic minority patients, families, and health care providers, and provide support for 7 additional positions. The proposed study seeks to: (1) delineate factors associated with engagement in clinical trials for pediatric patients with sickle cell disease (SCD) and their caregivers and (2) develop and pilot test a structured recruitment and retention protocol implemented through patient navigation. Low overall enrollment and poor retention has slowed progress towards identification of efficacious medical and psychosocial treatments for SCD, a genetic disorder affecting primarily African-Americans in the United States. Use of community-generated, empirically-based strategies to support engagement in clinical trials for pediatric patients with SCD and their caregivers will improve health care services for this population, by increasing access to clinical trials and enhancing the success of pediatric SCD clinical trials, and has applicability to other pediatric health disparity chronic illnesses.